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GRAS Notice 740 for Glycolipids from Dacryopinax Spathularia

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GRAS Notice 740 for Glycolipids from Dacryopinax Spathularia GRAS Notice (GRN) No. 740 https://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/default.htm l:•:.. •••••• TRS TOXICOLOGY REGULATORY SERVICES 26 October 2017 via UPS Paulette M. Gaynor, Ph.D. Senior Regulatory Health Project Manager Division of Biotechnology and GRAS Notice Review Office of Food Additive Safety (HFS-200) Center for Food Safety and Applied Nutrition Food and Drug Administration 500 1 Campus Drive College Park, MD 20740 Re: GRAS Notification for Long-Chain Glycolipids from Dacryopinax spathularia Dear Dr. Gaynor, In accordance with 21 CFR §170, Subpart E - Generally Recognized as Safe (GRAS) Notice, I am submitting, as the agent of the Notifier, IMD Natural Solutions GmbH, Otto-Hahn-Str. 15, 44227 Dortmund, Germany, a Notification regarding the conclusion of GRAS status for the use of long-chain glycolipids from Dacryopinax spathularia as an antimicrobial preservative in select non-alcoholic beverages. Enclosed is one printed copy of the Notification as well as an electronic copy of the Notification on CD. Please contact me with any questions. Best regards, (b) (6) lRi~~~G~\E\D) Andrey I. Nikiforov, Ph.D. OCT 3 0 2017 President OFFICE OF FOOD ADDITIVE SAFETY AIN/mor Enclosures 154 Hansen Road, Suite 201, Charlottesville, VA 22911, USA Telephone: +l 434-977-5957 • Facsimile: +1 434-977-1856 • [email protected] • www.toxregserv.com SAFETY EVALUATION DOSSIER SUPPORTING A GENERALLY RECOGNIZED AS SAFE (GRAS) CONCLUSION FOR THE USE OF LONG-CHAIN GLYCOLIPIDS FROM DACRYOPINAXSPATHULARIA IN NON-ALCOHOLIC BEVERAGES SUBMITTED BY: IMO Natural Solutions GmbH Otto-Hahn-Str. 15 44227 Dortmund, Germany SUBMITTED TO: U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition Office of Food Additive Safety (HFS-200) 5001 Campus Drive College Park, MD 20740 CONTACT FOR TECHNICAL OR OTHER INFORMATION: Andrey I. Nikiforov, Ph.D. Toxicology Regulatory Services (TRS), Inc. 154 Hansen Road, Suite 201 Charlottesville, VA 22911, U.S.A. October 26, 201 7 fR1~~~IlYJ~lQ) OCT 3 0 20l7 OFFICE OF FOOD ADDITIVE SAFETY Table of Contents Part 1. SIGNED STATEMENTS AND CERTIFICATION...........................................................1 A. Name and Address of Notifier .....................................................................................1 B. Name of GRAS Substance ...........................................................................................1 C. Intended Use and Consumer Exposure ........................................................................2 D. Basis for GRAS Conclusion ........................................................................................2 E. Availability of Information ..........................................................................................3 Part 2. IDENTITY, METHOD OF MANUFACTURE, SPECIFICATIONS, AND PHYSICAL OR TECHNICAL EFFECT ...................................................................4 A. Identity ..........................................................................................................................4 B. Production Process .......................................................................................................5 C. Product Characteristics .................................................................................................7 D. Physical or Technical Effect ......................................................................................10 Part 3. DIETARY EXPOSURE ...................................................................................................11 A. Intended Uses and Use Levels ....................................................................................11 B. Estimated Daily Intake (EDI) of Jelly Mushroom Glycolipids..................................11 Part 4. SELF- LIMITING LEVELS OF USE ................................................................................15 Part 5. EXPERIENCE BASED ON COMMON USE IN FOOD BEFORE 1958 .......................16 Part 6. BASIS FOR CONCLUSION OF GRAS STATUS FOR JELLY MUSHROOM GLYCOLIPIDS AM-1 (NARRATIVE) ...........................................................................17 Introduction ........................................................................................................................17 Historical Consumption .....................................................................................................18 Safety Assessment of Jelly Mushroom Glycolipids Production Organism .......................18 Absorption, Distribution, Metabolism and Excretion (ADME) Profile of Jelly Mushroom Glycolipids (AM-1) ......................................................................................21 Toxicology Profile of Jelly Mushroom Glycolipids (AM-1) .............................................32 Acute Toxicity, Irritation, and Sensitization Studies with Jelly Mushroom Glycolipids ................................................................................................................32 Assessment of Mutagenicity and Carcinogenicity Potential for Jelly Mushroom Glycolipids ................................................................................................................34 Genotoxicity Studies with Jelly Mushroom Glycolipids ..............................................35 Subchronic (Repeated Dose) Toxicity Studies with Jelly Mushroom Glycolipids ................................................................................................................36 Assessment of Reproductive and Developmental Toxicity Potential for Jelly Mushroom Glycolipids ..............................................................................................40 Rat Developmental Toxicity Study with Jelly Mushroom Glycolipids .........................40 Rat Two-Generation Reproduction Toxicity Study with Jelly Mushroom Glycolipids ................................................................................................................42 Safety Assessment of Jelly Mushroom Glycolipids Minor Component ............................45 Summary and Discussion of ADME and Toxicology Database for Jelly Mushroom Glycolipids ......................................................................................................................48 GRAS NOTIFICATION FOR JELLY MUSHROOM GLYCOLIPIDS (AM-1) i October 26, 2017 Part 6. BASIS FOR CONCLUSION OF GRAS STATUS FOR JELLY MUSHROOM GLYCOLIPIDS AM-1 (NARRATIVE) - continued Allergenicity ......................................................................................................................48 Summary of Safety Assessment and GRAS Conclusion ...................................................50 Acceptable Daily Intake (ADI) for Jelly Mushroom Glycolipids (AM-1) ....................50 Comparison of ADI and EDI for Jelly Mushroom Glycolipids (AM-1) .......................51 General Recognition of the Safety of Jelly Mushroom Glycolipids (AM-1) ................52 Part 7. LIST OF SUPPORTING DATA AND INFORMATION ................................................53 Listing of Figures Figure 1. Representative Structures for Jelly Mushroom Glycolipids (AM-1) ..............................4 Figure 2. Manufacturing Process Flow Diagram for Jelly Mushroom Glycolipids (AM-1) ..........6 Figure 3. Pariza and Johnson (2001) Decision Tree Analysis of Jelly Mushroom Glycolipids (AM-1) Production Organism, Dacryopinax spathularia MUCL 53181 .....................19 Figure 4. Proposed Degradation of Jelly Mushroom Glycolipids (AM-1) to LCFA....................22 Figure 5. Mean Concentration of Test Substance Equivalents in Rat Plasma (µg/g) following Oral Administration of [14C]-AM-1 or [14C]-LCFA .....................................28 Figure 6. Mean Concentration of Test Substance Equivalents in Rat Plasma (µg/g) following IV Administration of [14C]-AM-1 .................................................................29 Figure 7. Mean Concentration of Test Substance Equivalents in Rat Plasma (µg/g) following IV Administration of [14C]-LCFA ................................................................30 Listing of Tables Table 1. Specifications for Jelly Mushroom Glycolipids (AM-1) ..................................................9 Table 2. Proposed Uses and Maximum Use Levels of Jelly Mushroom Glycolipids (AM-1) .....11 Table 3. Estimated Daily Intake of Jelly Mushroom Glycolipids (AM-1) from Proposed Uses at Maximum Use Levels (Total U.S. Population) ................................................13 Table 4. Estimated Daily Intake of Jelly Mushroom Glycolipids (AM-1) from All Proposed Uses (Maximum Use Levels) by Population Subgroup (Infants, Children, Teenagers and Adults) ...................................................................................................13 Table 5. Experimental Design and Group Assignment During a Pharmacokinetics, Excretion Balance, and Tissue Distribution Study of [14C]-AM-1 and [14C]-LCFA in Sprague Dawley Rats ..................................................................................................................23 Table 6. Pharmacokinetics of Test Article Equivalents in Group 1 and Group 2 Rats following an Oral Dose of [14C]-AM-1 at 100 mg/kg or [14C]-LCFA at 46 mg/kg ......................26 Table 7. Pharmacokinetics of Test Article Equivalents in Group 3 and Group 4 Rats following an IV Dose of [14C]-AM-1 at 10 mg/kg or [14C]-LCFA at 4.6 mg/kg ..........................27 Table 8. Acceptable Daily Intake for Jelly Mushroom Glycolipids (AM-1) from Totality-of-Evidence .....................................................................................................51
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